Puncture site closure device

ABSTRACT

A laparoscopic fascial closure device ( 10 ) for fashioning a secure closure about a laparoscopic puncture site. The device comprises an elongate cannula ( 12 ) having proximal ( 12   a ) and distal ( 12   b ) ends. A needle suture complex ( 22 ) is selectively deployed from the distal end ( 12   b ) of the device that is operative to deploy a suture across the puncture site from within the body and draw the free ends of the suture outwardly from the body via the laparoscopic port site. The device ( 10 ) is configured to be utilized through a ten millimeter or larger laparoscopic port, and is operative to position the suture at the puncture site such that the suture extends in a diametrically-opposed configuration at least 1.0 cm or greater across opposed sides of the puncture site.

RELATED APPLICATIONS AND CLAIMS OF PRIORITY

This application claims priority to, and incorporates by reference inits entirety, co-pending U.S. patent application Ser. No. 10/086,318,filed Mar. 1, 2002, entitled “Laparoscopic Port Site Fascial ClosureDevice”.

BACKGROUND OF THE INVENTION

Laparoscopic, endoscopic, and thorascopic surgeries are well-knownsurgical techniques that advantageously reduces patient recovery timedue to minimal tissue damage, which consequently permits the patient toreturn to normal activity in a shorter period of time. Generally,surgery relies upon the formation of one or more trocar puncture woundsthrough which are deployed surgical instruments and a rod-like telescopewith a light source to enable the surgeon to view the organs and conductthe surgery.

Notwithstanding the tremendous advantages afforded by such surgicaltechniques, there still presents substantial clinical problems. Morespecifically, the puncture wounds created-within the body by the surgeonto gain access to the surgical site are often difficult andtime-consuming to close, and can place great demands on the surgeon.Such task is made even more difficult when such surgery is performedupon obese patients where there is a relatively deep puncture woundformed through a relatively small puncture site or incision. Indeed, thepuncture site frequently needs to be enlarged following the procedure toensure that the site is closed at the interior body cavity wall.Ironically, the need to enlarge the puncture site in order to adequatelyclose the same partially negates the primary advantages of this kind ofsurgery; however, such practice is essential insofar as failure toproperly close the puncture wound can lead to serious medicalcomplications.

To address such shortcomings, numerous attempts have been made todevelop instruments capable of quickly and effectively forming a closureof a fascial defect, or puncture site. Exemplary of such attemptsinclude those devices disclosed in U.S. Pat. No. 5,741,279, issued toGordon et al., on Apr. 21, 1998, entitled Endoscopic Suture System; U.S.Pat. No. 5,374,275, issued to Bradley et al., on Dec. 20, 1994, entitledSurgical Suturing Device and Method of Use; U.S. Pat. No. 5,964,773,issued to Greenstein on Oct. 12, 1999, entitled Laparoscopic SuturingDevice and Suture Needles; U.S. Pat. No. 5,403,329, issued toHinchcliffe on Apr. 4, 1995; and U.S. Pat. No. 5,507,757, issued toSauer et al. on Apr. 16, 1996, entitled Method of Closing PunctureWounds, the teachings of all of which are expressly incorporated hereinby reference.

Such attempts, however, have proven less than satisfactory and fail toprovide a practical solution to the foregoing problems. In this regard,substantially all such devices allegedly designed to facilitate theclosure of a laparoscopic, endoscopic, or thorascopic puncture site areincapable of deploying a suture a sufficient distance about the puncturesite to fashion an appropriate closure. In this respect, prior artdevices, such as those referenced above, are operative to stitch asuture into position at points diametrically across the puncture site;however, such suture typically only extends thereacross by a limiteddistance, which is less than 1.0 cm. In the case of laparoscopicsurgery, such limited distance fails to sufficiently approximate theperitoneum and fascia surrounding the puncture site sufficiently to forman adequate closure. While it is recognized that a suture extending agreater distance across the puncture site would be more advantageous,the capability of prior art devices position such a suture have notheretofore been available insofar as any fascial closure device mustnecessarily be insertable through a small endoscopic port, which may bea 10 mm laparoscopic port, which places considerable spacial constraintson the design of such devices.

Additionally disadvantages with such prior art closure devices includethe failure of such devices to selectively deploy needles forpositioning and stitching a suture across the puncture site that canultimately be withdrawn from the puncture wound without the need toenlarge the incision or puncture site. Among those devices possessingsuch defect include those disclosed in U.S. Pat. Nos. 5,964,733 and5,403,329, referenced above, which deploy needles that, after havingbeen deployed to fix a suture in position across an intra-abdominalpuncture site, are inoperative to become repositioned within the devicedeployed thereby to thus atraumatically withdraw such needles from thepatient.

Accordingly, there is a need for such a device that is capable of beingdeployed through a small diameter port or puncture site that is furthercapable of deploying a suture at a sufficient distance across theperiphery of the puncture to gather tissue and effect a secure closureof the fascial puncture site. There is additionally a need for such adevice that is capable of deploying a suture across a puncture,incision, or wound that provides for the retraction and capture ofneedles utilized to secure such suture in position back within thedevice deployed thereby to thus enable the needles to be easily andatraumatically withdrawn from the sutured puncture wound.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to a device that is operative tofashion a secure closure of incisions and puncture wounds in fascia andorgan tissues. According to a preferred embodiment, the device comprisesa needle/suture complex and a cannula or other hollow tubular memberhaving proximal and distal ends, the latter being configured to beinserted within the body via punctures or incisions used to performlaparoscopic, endoscopic, thorascopic and other such procedures. Thecannula or trocar is sized to be inserted through a puncture site inneed of closure or suture by the needle/suture complex.

More particularly, this device is useful for fashioning a closure of apuncture site in tissue using a cannula and connecting rod disposedwithin the cannula, which has an actuating mechanism formed toselectively advance or retract within the cannula, together with aneedle/suture complex mounted upon the connecting rod. The connectingrod is operatively transitional between multiple configurations of aneedle trap mechanism disposed within the lumen of the cannula. Theneedle trap mechanism preferably lockingly engages with the needles ofthe needle/suture complex to draw the needles into the lumen of thecannula, such that the device may be drawn from the body with the sutureextending between said needles, forming a closure of the puncture site.

Preferably, disposed within the cannula, and more particularly thedistal end thereof, is a needle/suture complex consisting of twodiametrically-opposed needle members having an elongate suture extendingtherebetween that are operatively transitional from a first insertionconfiguration, whereby the needles are confined within the distal-mostend of the cannula for insertion through the abdomen to the puncturesite; a second operative configuration whereby the needle members extendoutwardly from the distal-most end of the cannula such that eachrespective needle is oriented toward the fascia surrounding the puncturesite in a generally perpendicular orientation. Such needle members,according to said second configuration, are further oriented to extendoutwardly from the distal-most end of the cannula by a distance of atleast 1.0 cm or greater and pierce through the serous membrane ofvarious body cavities or tissues such as the pleura and peritoneum, andthen the fascia at diametrically opposed points across the puncture,incision, or wound site. To facilitate the ability of the needle/suturecomplex to gather tissue about a puncture site to form the desiredclosure, the needle/suture complex will preferably be positioned upon atapered mount having a generally hourglass shape to thus enable tissueto gather thereabout.

The needle members are further operative to assume a third retractionconfiguration whereby each respective tip of the twodiametrically-opposed needles are brought into and contained within thedistal end of the cannula. To facilitate the ability of the device toassume the third configuration, a grasping mechanism is disposed withinthe cannula that is operative to grasp each respective needle tip anddraw the same back into the cannula. The needle/suture complex ismounted upon a connecting rod disposed within the cannula, which isoperative to be advanced downwardly into the cannula such that theneedles of the needle/suture complex are deployed through and ultimatelyretracted back within the lumen of the cannula. When in such thirdconfiguration, the device is then withdrawn from the body.

In use, the suture connected across the respective needles is caused toextend across the puncture site with the free ends thereof being drawnupwardly from the puncture wound as the device is withdrawn from thebody, which thus leaves the two ends of the sutures free to be cut awayfrom the needles and then tied down to close the fascial defect.Advantageously, the suture made by the needle/suture complex ispositioned such that the suture extends a sufficient diameter from theperiphery of the puncture site, in relation to the diameter of thepuncture, such that a sufficient amount of tissue is utilized to givestrength to the closure. In one embodiment the suture made by theneedle/suture complex extends at least as far away from the periphery ofthe puncture as the diameter of the puncture. For example, a 5millimeter diameter puncture is sutured by a needle/suture complex thatextend 5 millmeters from the periphery of the puncture. Preferably thesuture made by the needle/suture complex is positioned such that thesuture extends at least 1 cm or greater across opposed sides of theperiphery of the puncture site, such that a sufficient amount of tissueis utilized to give strength to the closure. Additionally, such designadvantageously eliminates the need to deploy additional sutures acrossthe suture site, as is necessary with prior art needle passing deviceswhich must be passed multiple times across the puncture wound site. Thedevice further forms a closure in such a manner that thepneumoperitoneum is maintained, thus enabling the device to be utilizedwithout direct visualization with a laparoscope, endoscope, fiberscope,or other similar device.

Certain embodiments of the present invention provide a fascial puncturesite closure device that is capable of forming a closure about apuncture site utilizing a single deployment.

Another aspect of the present invention provides a fascial puncture siteclosure device that can form a closure about a puncture site in a mannerthat minimizes trauma to the patient.

Another aspect of the present invention provides a fascial puncture siteclosure device that forms a closure about a puncture site such that thepneumoperitoneum is maintained and the abdominal wall is kept away fromthe abdominal viscera.

Another aspect of the present invention provides a fascial puncture siteclosure device that is capable of being utilized without directvisualization.

BRIEF DESCRIPTION OF THE DRAWINGS

These, as well as other features of the present invention, will becomemore apparent upon reference to the drawings wherein:

FIG. 1 is a side, partial cross-sectional view of a fascial puncturesite closure device constructed in accordance with a preferredembodiment of the present invention.

FIG. 2 is an expanded cross-sectional view of the distal end of thedevice depicted in FIG. 1.

FIG. 3 is a cross-sectional view of the distal-most end of the devicedepicted in FIG. 2 shown deployed through a puncture site, incision,port, or wound through the skin, subcutaneous fat, fascia, and serousmembrane of a body cavity of a patient.

FIG. 4 is a cross-sectional view of the distal end of the devicedepicted in FIGS. 2-3 depicting a needle suture complex being deployedthrough the distal-most end thereof, the needle suture complex assumingan operative configuration for stitching a suture across the puncturesite formed within the fascia and serous membrane.

FIG. 5 is a cross-sectional view of the device depicted in FIGS. 2-4showing the needle/suture complex extending upwardly into the serousmembrane, fascia and subcutaneous fat layers.

FIG. 6 is a cross-sectional view of the device depicted in FIGS. 2-5,whereby the needles of the needle/suture structure are shown beingcaptured within the distal end of the device.

FIG. 7 is a cross-sectional view of the device depicted in FIGS. 2-6wherein the needles of the needle/suture complex are captured entirelywithin the distal end of the device as the device is shown being pulledupwardly from the puncture wound such that the suture of theneedle/suture complex remains fixed in position across the puncture siteformed through the skin, fascia and serous membrane.

FIG. 8 is a cross-sectional view depicting the placement of the suturefollowing withdrawal of the fascial puncture site closure device fromthe patient's body.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description set forth below is intended as a description ofthe presently preferred embodiment of the invention, and is not intendedto represent the only form in which the present invention may beconstructed or utilized. The description sets forth the functions andsequences of steps for constructing and operating the invention. It isto be understood, however, that the same or equivalent functions andsequences may be accomplished by different embodiments and that they arealso intended to be encompassed within the scope of the invention.

More specifically, the present invention is directed to a device that isoperative to fashion a secure closure or suture of incisions orpunctures, in organs, vasculature, and or tissues surrounding a cavityof the body. According to a preferred embodiment, the device comprisesan elongate cannula or trocar or other hollow housing member havingproximal and distal ends, the latter being configured to be insertedwithin the body through the puncture and used with a needle/suturecomplex to perform the closure or suture procedure. The housing cavitymay be any shape including but not limited to square, rectangular, ortriangular channel. Preferably the housing is tubular or cylindrical inshape. Preferably the size of the cannula and the needle/suture complexis such that the cavity of the body may be insufflated and or maintainedat a desired pressure with the cannula in place and that a suturesufficiently spaced from the edge of the periphery of the puncture maybe made with the needle/suture complex to gather the tissue and form thedesired closure.

A fiberscope is a flexible fiberoptic scope which may be used forvisualizing tissue, organs, body cavities or vasculature. Endoscopyrefers to the visual inspection of any cavity of the body by means of anendoscope. For example, peroral endoscopy is examination of organsaccessible to observation through an endoscope passed through the mouth,and transcolonic endoscopy is examination of the colon by means of anendoscope inserted through a trocar or cannula into an incision into thecolon wall. A laparoscope is an instrument comparable to an endoscope,and in a laparoscopic procedure is usually inserted into the peritonealcavity using a cannula or trocar to inspect it. Thoracoscopy isexamination of the pleural cavity, also called a plueroscopy, containingor investing the lung and lining the thoracic cavity. Feed tubes orother devices may also be placed or implanted in a body cavity or organthrough an incision or trocar puncture. Upon removal, the incision orpuncture through which the trocar, tubes, or leads are passed to thecavity or organ may require a suture sufficiently spaced from the edgeof the periphery of the feedthrough puncture to gather the tissue andform the desired closure.

Referring now to the Figures, and initially to FIG. 1, there is shown asuture or closure device 10 constructed in accordance with a preferredembodiment of the present invention. As illustrated, the device 10comprises an elongate cannula or trocar member 12 having proximal anddistal ends 12 a, 12 b, with the distal end 12 b being operative forinsertion into the patient, and the proximal end 12 a having a handle 14and actuation mechanisms 16, 18 to facilitate handling and operation ofthe device by a surgeon, discussed more fully below.

Axially disposed within the lumen of the cannula 12 is an elongateconnecting rod 20 having a proximal end 20 a that is secured to atrigger mechanism 16 extending outwardly from a position near or uponthe proximal end 12 a of the cannula 12. As will be appreciated by thoseskilled in the art, the trigger mechanism 16 cooperates with the handle14 formed near or upon the proximal end 12 a of the cannula 12 to thusenable a surgeon to simultaneously grasp and operate the device 10. Thedistal end 20 b of the connecting rod 20 is coupled to a needle/suturecomplex 22, more clearly seen in FIG. 2, the latter consisting of anopposed pair of angled needle holders 24 a, 24 b pivotally connected tothe connecting rod 20, an opposed pair of angled needles 26 a, 26 breceived within dedicated ones of the needle holders 24 a, 24 b, and anelongate suture 28 having a first end attached to a respective one ofthe needles, and the other end attached to the respective other end ofthe needle. The needle/suture complex 22 will further preferably bepositioned upon a tapered mount 30 having a generally hourglass shape tofacilitate the ability of the device to form a closure, discussed morefully below, as more clearly seen in FIG. 6.

Additionally provided within the device 10 of the present invention is aneedle trap mechanism 32, more clearly depicted in FIG. 2, comprised ofan elongate cylindrical sleeve axially mounted about a portion of theconnecting rod 20. The needle trap includes a proximal end 32 a having ahandle or other graspable member formed thereon, shown as 18 in FIG. 1,the latter extending partially from the cannula member 12 to thus enablea surgeon to manipulate the same. Formed upon the distal end 32 b of theneedle trap is a generally bell-shaped or frusto-conical shaped housing34 operative to grasp the tips of the opposed needles 26 a, 26 b andultimately contain the same therewithin such that the needles 26 a, 26 bmay ultimately be pulled from their respective needle holders 24 a, 24 bwithin which they are received following deployment of the device 10 andcontained within the cannula 12, as discussed more fully below.

The device 10 of the present invention is specifically configured to bedeployed through incisions, wounds, endoscopic, laparoscopic orthorascopic ports, and other such puncture sites in a patient.Preferably the puncture site has a size of at least about 10 mm orgreater. As will be recognized by those skilled in the art, althoughcertain laparoscopic procedures are performed utilizing laparoscopicports of less than 10 mm, by far the majority of such laparoscopic,endoscopic or thorascopic procedures rely upon at least one or morelarger ports having a size of 10 mm or greater. It should be understood,however, that the present invention could be adapted for deploymentthrough smaller ports, as may be necessary in other applications.

Referring now to FIG. 3, there is shown the distal end of the device 10depicted in FIGS. 1-2 shown deployed through the distal end of apuncture, wound, incision, or port and within the abdominal cavity of apatient. The patient may be any mammal or animal in need of closure of apuncture or wound. As discussed above, the distal end of the device 10will be inserted through a port. The formation of ports or punctures forendoscopic, laparoscopic, and thorascopic procedures is well-known inthe arts and utilized extensively in the practice of such surgery.Briefly, such ports are formed via the use of trocars followed by theplacement of a port into the patient, the latter defining a channelthrough which surgical instruments and implants such as tubes,feedthrough for fluids, gases, power, endoscopes, and laparoscopes aredeployed for a given surgical procedure. The device 10 of the presentinvention is specifically used following the surgical procedure to forma closure about the puncture site within the body through which the portwas utilized. Initially, the distal end of the device 10 is insertedthrough the port such that the distal-most end of the device 10 extendsinto a body cavity, such as but not limited to the peritoneal cavity orthe thoracic cavity, through layers of skin 36, subcutaneous fat 38,fascia 40, and serous membrane 42. The connecting rod 20 is thenactuated via the trigger (not shown) such that the connecting rod 20extends downwardly through the distal end 12 b of the cannula 12 suchthat the needle/suture complex 22 is caused to extend therefrom. Asillustrated, the needle/suture complex 22 will be deployed within thebody cavity or organ, and beneath the skin 36, subcutaneous fat 38,fascia 40 and peritoneal 42 layers through which the port extends.Puncture sites in body cavities and organs which may be closed byembodiments of the present invention may include but are not limited tothe peritoneal cavity, the thoracic cavity, and the colon.

Once the needle/suture complex 22 is caused to extend through thedistal-most end 12 b of the cannula 12, the needle/suture complex 22transitions from its first, folded configuration depicted in FIGS. 2-3to a second operative configuration, as illustrated in FIG. 4. In suchoperative configuration, the needle holder arms 24 a, 24 b pivotoutwardly such that the needles 26 a, 26 b held thereby spread out andextend away from the distal opening of the cannula 12 a. To achieve thatend, it is contemplated that the needle holder arms 24 a, 24 b may beoutwardly biased via the use of springs or some other biasing force. Asillustrated, the needle holder arms 24 a, 24 b and needles 26 a, 26 bheld thereby are formed to have bends therein to thus enable the needles26 a, 26 b to achieve an orientation whereby the needles are positionedin a substantially perpendicular fashion relative to the serous membrane42 and fascia 40, and generally parallel to the cannula 12 of the device10. The arms 24 a, 24 b and needles 26 a, 26 b are further configuredsuch that the same extend from the distal-most end of the cannula 12 andin diametrically opposed directions from the periphery of the wound,incision, port opening or puncture site, by a distance sufficient togather the tissue to form a secure closure. Preferably the distance theneedles extend from the periphery of the port or puncture is at least 1centimeter or greater.

In this respect, one of the chief advantages of the operation of thedevice 10 of the present invention is the ability of the same toultimately stitch a suture into position a sufficient distance about theport opening or periphery to thus cause a more secure closure toultimately be formed. Prior art devices, in contrast, are incapable ofdelivering a suture sufficiently across a puncture wound site to fashiona desired secure closure within the patient's body cavity or organ.

To that end, there is shown in FIG. 5 the process by which the suture28, as deployed by the needle/suture complex 22, is positioned across apuncture site. The opposed needles 26 a, 26 b extend upwardly andpenetrate the serous membrane 42 and fascia 40 in a generallyperpendicular fashion and are operative to traverse the serous membrane42, subcutaneous fat 38 and fascia 40 prior to being captured within thelumen of the cannula 12, discussed more fully below. As will beappreciated, such pathway of penetration defined by the opposed needles26 a, 26 b provide for substantially more secure suture placement. Tofacilitate the ability of the device 10 to form a closure of thepuncture site via placement of the suture 28, tapered mount 30 uponwhich the needle/suture complex 22 is positioned enables tissue to begathered radially thereabout.

In order to safely and atraumatically withdraw the needles 26 a, 26 bdeploying the suture 28 about the puncture site, there is further shownin FIG. 6 a mechanism by which the present invention operates toaccomplish same. As illustrated, the needle/suture complex 22 isoperative to assume a third retraction configuration whereby the tips ofthe respective needles 26 a, 26 b are captured by the needle trapmechanism 32, and ultimately caused to detach from the respective needleholders 24 a, 24 b and remain contained within the cannula 12 of thedevice 10. Specifically, as the connecting rod 20 is pushed downwardly,the needle holder arms 24 a, 24 b are forced to rotate inwardly. Suchmotion consequently causes the needle tips of the opposed needles 26 a,26 b to likewise rotate inwardly, such that the tips are received withinthe capture area 34 formed upon the distal-most end of the needle trapmechanism 32 positioned axially about the connecting rod 20. Oncecaptured, the needle trap mechanism 32, with needle tips capturedthereby, is pulled upwardly through the cannula 12 via a lever (i.e.,lever 18 in FIG. 2) formed on the proximal end thereof extending fromthe cannula 12 such that each respective needle 26 a, 26 b is caused todislodge from the needle holder arm 24 a, 24 b that it had respectivelyengaged. As a consequence, the needles 26 a, 26 b become disengaged fromthe needle suture complex 22 and are ultimately contained safely withinthe lumen of the cannula 12.

As illustrated in FIG. 7, as a result of the removal of the needles 26a, 26 b from the needle holder arms 24 a, 24 b, the needles 26 a, 26 bare caused to advance upwardly through the cannula 12 with the sutureends remaining attached thereto. As will be readily appreciated, byvirtue of having been stitched across opposed sides of the incision,wound, port or puncture site, the suture 28 will extend thereacross andupwardly through the piercings made by the respective needles 26 a, 26 bthrough the peritoneum 42, fascia 40, fatty tissue 38 and ultimatelythrough the previously formed port channel. As will be appreciated, suchsuture 28 will be pulled through the body by merely withdrawing theentire device 10 from the patient, as shown in FIG. 6.

Ultimately, the suture 28 will be positioned across the port or puncturesite in the manner depicted in FIG. 8. As illustrated, the respectiveends of the suture 28 will extend outwardly from the body but around thepuncture site to thus fashion a closure of the site. To that end, thesuture 28 may be manipulated according to a variety of techniques tothus ensure that the puncture site remains closed thereby.

Additional modifications and improvements of the present invention mayalso be apparent to those of ordinary skill in the art. For example, itis contemplated that a variety of mechanisms exist that are capable ofcapturing needle tips of the needles deployed by the needle/suturecomplex 22 of the present invention. Additionally, it is contemplatedthat a variety of needles, needle sizes, and needle/holderconfigurations may be derived that are capable of causing the needles toultimately penetrate through the organ tissue, serous membrane, fasciaand fatty tissue, in a generally perpendicular orientation, and furtherare caused to advance through such tissues at a distance sufficient fromthe periphery of the puncture site sought to be closed. Moreover, avariety of mechanisms may be utilized to deploy the needle/suturecomplex, which may include a connecting rod configured to retract,twisted or otherwise manipulated to cause the needle/suture complex totransition to its various operative configurations. Thus, the particularcombination of parts and steps described, and illustrated herein isintended to represent only certain embodiments of the present invention,and is not intended to serve as limitations of alternative devices andmethods within the spirit and scope of the invention.

1. A device for fashioning a closure of a puncture site in a tissuecomprising: a cannula member having proximal and distal ends and alumen; a connecting rod disposed axially within said cannula, saidconnecting rod having a proximal end oriented towards said proximal endof said cannula and a distal end oriented toward said distal end of saidcannula, said connecting rod having a actuating mechanism operative toselectively cause said connecting rod to advance distally or retractproximally within said cannula; a needle/suture complex mounted uponsaid distal end of said connecting rod, said needle/suture complexcomprising at least one pair of needles having a suture extendingtherebetween, said needles being operative to assume an operativeconfiguration wherein said needles extend in opposed directions from thedistal end of said cannula such that each respective needle extends froma periphery of a puncture site; and a needle trap mechanism disposedwithin the lumen of said cannula and operative to lockingly engage saidneedles of said needle/suture complex when said needles assume theoperative configuration; and wherein said needle trap mechanism isoperative to draw said needles into the lumen of said cannula such thatthe device may be withdrawn from the puncture site with the sutureextending between the needles, forming a closure of said puncture site.2. The device of claim 1, wherein said needless and further operative toassume one or both of the following additional configurations: a foldedconfiguration wherein said needles are operative to extend through thelumen of said cannula; and a retracted configuration wherein saidneedles are biased inwardly toward the lumen of said cannula;
 3. Thedevice of claim 2 wherein the distal end of said cannula is positionablethrough a puncture site in a tissue.
 4. The device of claim 2 whereinsaid needle/suture complex further comprises at least one pair of needleholder arms, each respective one of said at least one pair of saidneedle holder arms being operative to receive a respective one of saidpair of needles.
 5. The device of claim 4 wherein each respective one ofsaid pair of needles is operative to disengage from said needle holderarms as said needle/suture complex transitions from its second operativeconfiguration to its third operative configuration.
 6. The device ofclaim 2 wherein each respective one of said pair of needles are biasedto extend in diametrically opposed directions across said puncture siteas said needle/suture complex assumes said second operativeconfiguration.
 7. The device of claim 4 wherein each respective one ofsaid pair of needle holder arms are biased to extend in diametricallyopposed directions across said puncture site as said needle holder armsassume said second operative configuration.
 8. The device of claim 1further comprising a handle formed upon said cannula.
 9. The device ofclaim 8 wherein said handle and said trigger are positioned relative oneanother to enable the handle to be grasped and the trigger to bemanipulated by a single hand of a user.
 10. The device of claim 2wherein said needle trap mechanism comprises a cylindrical sleeveaxially mounted about said connecting rod within said cannula, saidneedle trap mechanism having a proximal end with a lever formed thereon,extending from said cannula, and a bell-shaped distal end having aneedle catch formed therein, said needle catch being operative tolockingly engage with said needle tips of said needle/suture complexwhen said complex assumes said third operative configuration.
 11. Thedevice of claim 10 wherein said lever formed upon said needle trapmechanism is operative to cause said needle trap mechanism to extenddistally and retract proximally within the said cannula.
 12. The deviceof claim 11 wherein said needle trap mechanism, when lockingly engagedwith said needle tips of said needles, captures said needles within saidcannula when said needle trap mechanism retracts proximally within saidcannula.
 13. The device of claim 1 further comprising a tapered mountformed upon said distal end of said connecting rod and holding saidneedle/suture complex, said tapered mount having a generally hourglassshape.
 14. The device of claim 1 wherein said actuating mechanism is atrigger.